Regulatory Brief

 Comment on FDA Transparency Initiative


Formal title: Docket Number [FDA-2009-N-0247] FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration; Availability

The AVMA provided comments regarding the veterinary profession's perspectives and potential enhancements to FDA Transparency Initiative.

Brief Description:

The comments submitted by the AVMA were in reference to the FDA's request for such by its stakeholders and the general public on the Transparency Task Force Report, "FDA Transparency Initiative: Draft Proposals for Public Comment Regarding Disclosure Policies of the U.S. Food and Drug Administration". The Report is a component of the second of three phases of the FDA Transparency Initiative, which was launched during the summer of 2009.

AVMA Response:

The AVMA applauds the introspective efforts made by the FDA as well as its public outreach to enhance the Agency's transparency and functionality. While the AVMA recognizes potential benefits in all of the twenty-one proposals developed by the Task Force, our comments are confined to the top few proposals which could impart the greatest impact on veterinary medicine – those within the broader categories titled "Adverse Events," "Recalls," and "Product Applications."

Adverse Events:

  • Being committed to the continuing availability of the medicinal products that are pure, safe, potent, and efficacious for animals, the AVMA encourages continued development and strengthening of adverse event reporting systems. This includes continued collaboration with constituent professional organizations, industry organizations, government entities and other stakeholders.
  • The system described in the proposal could yield a versatile database of extremely useful and pertinent information beneficial to animal and public health. Specifically, the AVMA asserts that the system needs ongoing efforts to improve the accuracy of the system with as much human bias removed as possible.

Recalls:

  • An accurate and expeditious means for communicating recall information to the public and FDA stakeholders is imperative. This includes providing clarification for which products are and are not involved as well as when recalls have been terminated.

Product Applications:

  • The AVMA is not seeking publication of proprietary information. We suggest that information sharing and regarding why product applications are abandoned, withdrawn, or denied is important, especially in the instances related to safety of issues or detrimental effects associated with the product. Such communication could potentially reduce pain and suffering of our animal patients.
  • Labels that accompany animal drugs should provide relevant pharmacokinetic and pharmacodynamic data necessary for the rational design of dosing regimens specific for the individual patient. If these data cannot be incorporated into drug labels, having access to this clinically relevant information would be a valued resource by our profession.

Background Documents:

View AVMA's submitted comments to FDA (PDF)

View Federal Register document (PDF)

Status:

The AVMA submitted comments on July 20, 2010.